Recently, the preferred FDA Substance Registration System (SRS) term "hypromellose" was changed to "hypromelloses."
This change is related to the preferred term used in the product data elements (drug listing) section of the content of labeling/listing SPL document. This change does NOT affect the utilization of the term "hypromellose" in the content of labeling (package insert or drug facts) sections of an SPL document.
Per the FDA SRS team, the term change more clearly represents the code as being associated with a family of polymers rather than a single substance. The change is intended to encourage SPL authors to choose more granular terms and codes for their listings submissions.
More granular available UNIIs are listed below. The terms also reflect a recent change by USP to SI viscosity units (MPA.S from CPS).
HYPROMELLOSE 2208 (100 MPA.S) B1QE5P712K
HYPROMELLOSE 2208 (100000 MPA.S) VM7F0B23ZI
HYPROMELLOSE 2208 (15000 MPA.S) Z78RG6M2N2
HYPROMELLOSE 2208 (3 MPA.S) 9H4L916OBU
HYPROMELLOSE 2208 (4000 MPA.S) 39J80LT57T
HYPROMELLOSE 2906 (4000 MPA.S) 5EYA69XGAT
HYPROMELLOSE 2906 (50 MPA.S) 612E703ZUQ
HYPROMELLOSE 2910 (15 MPA.S) 36SFW2JZ0W
HYPROMELLOSE 2910 (15000 MPA.S) 288VBX44JC
HYPROMELLOSE 2910 (3 MPA.S) 0VUT3PMY82
HYPROMELLOSE 2910 (4000 MPA.S) RN3152OP35
HYPROMELLOSE 2910 (5 MPA.S) R75537T0T4
HYPROMELLOSE 2910 (50 MPA.S) 1IVH67816N
HYPROMELLOSE 2910 (6 MPA.S) 0WZ8WG20P6
ETHYLCELLULOSE (10 MPA.S) 3DYK7UYZ62
ETHYLCELLULOSE (100 MPA.S) 47MLB0F1MV
ETHYLCELLULOSE (14 MPA.S) 589D1IWM11
ETHYLCELLULOSE (20 MPA.S) BJG0S321QY
ETHYLCELLULOSE (4 MPA.S) KC5472WRJK
ETHYLCELLULOSE (45 MPA.S) V7AD894FAZ
ETHYLCELLULOSE (50 MPA.S) 6I475159RA
ETHYLCELLULOSE (7 MPA.S) H3UP11403C
Note: It is expected that a similar change will be made for POLYETHYLENE GLYCOL and all other polymers for which the FDA SRS team has created a generic term and code in the very near future. The FDA SRS team has avoided the POLYETHYLENE GLYCOL change because it affects so many products but low molecular weight polyethylene glycols pose significant safety issues so identifying the specific polyethylene glycol is important. If you have any questions or comments regarding this SRS preferred term, please send your questions or comments to spl@fda.hhs.gov.
Hypermelloses
Recently, the preferred FDA Substance Registration System (SRS) term "hypromellose" was changed to "hypromelloses."
This change is related to the preferred term used in the product data elements (drug listing) section of the content of labeling/listing SPL document. This change does NOT affect the utilization of the term "hypromellose" in the content of labeling (package insert or drug facts) sections of an SPL document.
Per the FDA SRS team, the term change more clearly represents the code as being associated with a family of polymers rather than a single substance. The change is intended to encourage SPL authors to choose more granular terms and codes for their listings submissions.
More granular available UNIIs are listed below. The terms also reflect a recent change by USP to SI viscosity units (MPA.S from CPS).
HYPROMELLOSE 2208 (100 MPA.S) B1QE5P712K
HYPROMELLOSE 2208 (100000 MPA.S) VM7F0B23ZI
HYPROMELLOSE 2208 (15000 MPA.S) Z78RG6M2N2
HYPROMELLOSE 2208 (3 MPA.S) 9H4L916OBU
HYPROMELLOSE 2208 (4000 MPA.S) 39J80LT57T
HYPROMELLOSE 2906 (4000 MPA.S) 5EYA69XGAT
HYPROMELLOSE 2906 (50 MPA.S) 612E703ZUQ
HYPROMELLOSE 2910 (15 MPA.S) 36SFW2JZ0W
HYPROMELLOSE 2910 (15000 MPA.S) 288VBX44JC
HYPROMELLOSE 2910 (3 MPA.S) 0VUT3PMY82
HYPROMELLOSE 2910 (4000 MPA.S) RN3152OP35
HYPROMELLOSE 2910 (5 MPA.S) R75537T0T4
HYPROMELLOSE 2910 (50 MPA.S) 1IVH67816N
HYPROMELLOSE 2910 (6 MPA.S) 0WZ8WG20P6
ETHYLCELLULOSE (10 MPA.S) 3DYK7UYZ62
ETHYLCELLULOSE (100 MPA.S) 47MLB0F1MV
ETHYLCELLULOSE (14 MPA.S) 589D1IWM11
ETHYLCELLULOSE (20 MPA.S) BJG0S321QY
ETHYLCELLULOSE (4 MPA.S) KC5472WRJK
ETHYLCELLULOSE (45 MPA.S) V7AD894FAZ
ETHYLCELLULOSE (50 MPA.S) 6I475159RA
ETHYLCELLULOSE (7 MPA.S) H3UP11403C
Note: It is expected that a similar change will be made for POLYETHYLENE GLYCOL and all other polymers for which the FDA SRS team has created a generic term and code in the very near future. The FDA SRS team has avoided the POLYETHYLENE GLYCOL change because it affects so many products but low molecular weight polyethylene glycols pose significant safety issues so identifying the specific polyethylene glycol is important. If you have any questions or comments regarding this SRS preferred term, please send your questions or comments to spl@fda.hhs.gov.